Becker's Healthcare March 16, 2023
The FDA has updated its guidance on using EHRs and electronic signatures in clinical trials to account for technological advances since the agency last updated its guidance in 2017, RegulatoryFocus reported March 15.
The updates provide recommendations for applying data integrity and data security tools to clinical trials.
The agency reiterated that sponsors and entities are responsible for ensuring that the records they submit through vendors comply with FDA regulations.
“In addition,...
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